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CTRI Number  CTRI/2022/08/044780 [Registered on: 22/08/2022] Trial Registered Prospectively
Last Modified On: 21/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to check effect of two drugs bruhatlashunpinda and rasnasaptak kwatha on patients with manyastambha with special reference to cervical spondylosis.  
Scientific Title of Study   Randomized controlled clinical study to evaluate efficacy of bruhatlashunpinda and rasnasaptak kwatha in the management of manyastambha with special reference to cervical spondylosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prachi Dhananjay Patwari 
Designation  PG scholar 
Affiliation  D. Y. Patil School of Ayurveda 
Address  school of Ayurveda, D.Y. Patil Vidyanagar, sector 7, Nerul, Navi Mumbai, Thane, Maharashtra-400706.
school of Ayurveda, D.Y. Patil Vidyanagar, sector 7, Nerul, Navi Mumbai, Thane, Maharashtra-400706.
Thane
MAHARASHTRA
400706
India 
Phone  9028191514  
Fax    
Email  prachidk10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prachi Dhananjay Patwari 
Designation  PG scholar 
Affiliation  D. Y. Patil school of Ayurveda 
Address  school of Ayurveda, D.Y. Patil Vidyanagar, sector 7, Nerul, Navi Mumbai, Thane, Maharashtra. India. 400706
school of Ayurveda, D.Y. Patil Vidyanagar, sector 7, Nerul, Navi Mumbai, Thane, Maharashtra-400706
Thane
MAHARASHTRA
400706
India 
Phone  9028191514  
Fax    
Email  prachidk10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neena Damle 
Designation  Assistant Professor 
Affiliation  D. Y. Patil School of Ayurveda 
Address  school of Ayurveda, D.Y. Patil Vidyanagar, sector 7, Nerul, Navi Mumbai, Thane, Maharashtra-400706
school of Ayurveda, D.Y. Patil Vidyanagar, sector 7, Nerul, Navi Mumbai, Thane, Maharashtra-400706
Thane
MAHARASHTRA
400706
India 
Phone  7977153510  
Fax    
Email  neena.damle@dypatil.edu  
 
Source of Monetary or Material Support  
school of Ayurveda, D. Y. Patil Deemed to be University, Nerul, Navi Mumbai-400706 
 
Primary Sponsor  
Name  Dr Prachi Patwari  
Address  Kayachikitsa Department, school of Ayurveda, D. Y. Patil Deemed to be University, Nerul, Navi Mumbai 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prachi Dhananjay Patwari  D. Y. Patil School of Ayurveda  Room no. 1, Kayachikitsa department, School of Ayurveda, D. Y. Patil Deemed to be University, D.Y. Patil Vidyanagar, sector 7, Nerul, Navi Mumbai, Thane, Maharashtra-400706
Thane
MAHARASHTRA 		 9028191514

prachidk10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M471||Other spondylosis with myelopathy. Ayurveda Condition: MANYASTAMBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Bruhatlashunpinda, Reference: Gadanigraha Prayogkhande Gutikaadhikar 291-297, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Rasnasaptak Kwatha, Reference: Bhaishajyaratnavali Vatvyadhi Rogadhikar 26/70, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Well diagnosed patients of manyastambha (Cervical spondylosis).
2.Subjects having neck pain with or without radicular symptoms paresthesia since more than two months.
3.Cervical spondylitis confirmed by radiological assessment (X ray cervical vertebrae AP and lateral view.
4.Subjects were willing to give informed consent and ready to comply with the protocol.
5.Subjects who are ready to provide regular follow ups till completion of the study. 
 
ExclusionCriteria 
Details  1.Known cases of trauma of neck, local wound and infection over neck, cervical rib syndrome, any spinal cord disorders other than cervical spondylosis & myelopathy.
2.Known cases of shoulder and elbow musculoskeletal problems, fracture of spine and upper limb.
3.Known cases of inflammatory arthritis.
4.Subjects who use any other investigational drug within one month prior to randomization.
5.Known cases of Tuberculosis, HIV, Ischemic heart disease, Cancer.
6.Known cases of Hypertension, Hyperacidity, Peptic ulcer, Duodenal ulcer.
7.Pregnancy and Lactation.
8.Other conditions, which in the opinion of investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Visual Analog Scale, Neck Disability Index, Goniometry readings and neck pain, stiffness, restricted neck movements.   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  it will be made available if requested through e-mail (prachidk10@gmail.com).

  6. For how long will this data be available start date provided 15-06-2022 and end date provided 15-06-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

TITLE OF DISSERTATION

 

RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE EFFICACY OF BRUHATLASHUNPINDA AND RASNASAPTAK KWATHA IN THE MANAGEMENT OF MANYASTAMBHA WITH SPECIAL REFERENCE TO CERVICAL SPONDYLOSIS.


AIMS AND OBJECTIVES

 AIMS-

 To study and compare the effect of Bruhatalashunapinda and Rasnasaptak kwatha in the management of Manyastambha with special reference to Cervical spondylosis.

 

OBJECTIVES-

1) To evaluate efficacy of Bruhatalashunapinda in the management of Manyastambha with special reference to cervical spondylosis.

3) To evaluate efficacy of Rasnasaptak kwatha in the management of Manyastambha with special reference to cervical spondylosis.

2) To study Manyastambha in detail according to Ayurved Samhita and cervical spondylosis according to modern view.


HYPOTHESIS

NULL HYPOTHESIS-

Effect of Bruhatalashunapinda is not significant than Rasnasaptak kwatha in the management of Manystambha with special reference to cervical spondylosis.

 

 ALTERNATE HYPOTHESIS-

Effect of Bruhatalashunapinda is significant than Rasnasaptak kwatha in the management of Manystambha with special reference to cervical spondylosis.


RESEARCH QUESTION

PRIMARY RESEARCH QUESTION

Is there any significant difference between Bruhatlashunpinda and Rasnasaptak kwatha in the management of Manyastambha with special reference to Cervical spondylosis?

SECONDARY RESEARCH QUESTION

 Is Bruhatlashunpinda is effective in the management of Manyastambha with special reference to Cervical spondylosis?

METHOD OF COLLECTION OF DATA

Considering 20% Dropout rate, we propose to enroll 72 subjects (36 in each group) to get 60 evaluable cases (30 in each group) at the end of the study. These subjects will be fulfilling inclusion Criteria, which will be selected from D.Y. Patil Ayurvedic Hospital Nerul Navi Mumbai OPD No.1 and IPD (Kayachikitsa department) and randomly divided into two groups –Group A and B. Group A subjects will be treated with Bruhatalashunapinda and Rasnasaptak Kwatha and Group B Subjects will be treated with Rasnasaptak Kwatha  (Control group) for 28 days. levels of improvement will be recorded in three visits v1,v2,v3. Each visit will be 7 days apart.


DIAGNOSTIC CRITERIA

1)          Pain (Ruja)

2)          Stiffness (Stambha)

3)          Restricted neck movements.

 
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